Cleared Traditional

K811936 - CHEMICAL AUTOCLAVE INDICATOR TAPE

K811936 is an FDA 510(k) clearance for CHEMICAL AUTOCLAVE INDICATOR TAPE, manufactured by American Hospital Supply Corp.. The device is a Class 2 General Hospital device with product code JOJ cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K811936 · American Hospital Supply Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1981
Decision
22d
Days
Class 2
Risk

K811936 is an FDA 510(k) clearance for the CHEMICAL AUTOCLAVE INDICATOR TAPE. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by American Hospital Supply Corp. (Mchenry, US). The FDA issued a Cleared decision on July 28, 1981 after a review of 22 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2800 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all American Hospital Supply Corp. devices

FDA 510(k) Submission Details - K811936

510(k) Number K811936 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1981
Decision Date July 28, 1981
Days to Decision 22 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 129d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOJ Device Classification - Class 2, Special Controls

Product Code JOJ Indicator, Physical/chemical Sterilization Process
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - JOJ Indicator, Physical/chemical Sterilization Process

All 202
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K811936.
CHEMDI STEAM & GAS STERILIZATION INDICA
K823074 · American Sterilizer Co. · Nov 1982
GAS CHEX PLASTIC BAG
K821648 · Propper Mfg. Co., Inc. · Jun 1982
PROTECT-O-SEAL
K813014 · Tri-Med, Inc. · Nov 1981
CASTLE STEAM STERILIZATION INDICATOR
K810614 · Sybron Corp. · Jun 1981
STERIGAGE EO ETHYL. OXIDE STERIL. INDIC.
K802634 · Organon, Inc. · Dec 1980
CHEMDI
K801428 · American Sterilizer Co. · Aug 1980